Risk of neuroleptic malignant syndrome: In the event of hyperthermia, particularly with high daily doses, all antipsychotic drugs including amisulpride should be discontinued.
Risk of hyperglycaemia: Patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.
Patient with renal insufficiency: The dose should be decreased or intermittent treatment could be considered.
Patients with a history of epilepsy: Need to closely monitor during amisulpride therapy.
Elderly patients: Caution because of a possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency.
Patients with Parkinson’s disease: Caution should be also exercised when prescribing amisulpride, amisulpride should be used only if neuroleptic treatment cannot be avoided.
Gradual withdrawal of amisulpride is advisable to avoid withdrawal symptoms.
Patients with stroke risk factors: Amisulpride should be used with caution.
Elderly patients with dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Amisulpride is not licensed for the treatment of dementia-related behavioural disturbances.
Venous thromboembolism: All possible risk factors for VTE should be identified before and during treatment with amisulpride and preventive measures undertaken.
Breast cancer: Caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during amisulpride therapy.
Benign pituitary tumour: In case of very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be stopped.
- Leukopenia, neutropenia and agranulocytosis have been reported. Unexplained infections or fever may be evidence of blood dyscrasia, and requires immediate haematological investigation.
- Prolongation of the QT interval:
Amisulpride induces a dose-dependent prolongation of the QT interval. This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes. Before any administration, and if possible according to the patient’s clinical status, it is recommended to exclude the following factors which could favour the occurrence of this rhythm disorder:
- Bradycardia less than 55 bpm.
- Cardiac disease or family history of sudden death or QT prolongation.
- Electrolyte imbalance, in particular hypokalaemia.
- Congenital prolongation of the QT interval.
- On-going treatment with a medicinal product likely to produce pronounced bradycardia (< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QT interval.
Baseline ECG is recommended prior to treatment in all patients especially in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination. During therapy, the need for ECG monitoring (e.g. at dose escalation) should be assessed on an individual patient basis. The dose of amisulpride should be reduced if QT is prolonged and discontinued if QTc is > 500 ms.
Periodic electrolyte monitoring is recommended particularly if the patient is taking diuretics or during inter-current illness.
Concomitant use with antipsychotics should be avoided.
Severe liver toxicity: Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician. Investigations including clinical examination and biological assessment of liver function should be undertaken immediately.
Sulpistad 400 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use of the drug is not recommended during pregnancy unless the benefits justify the potential risks. Breast-feeding is contraindicated.
Patients should be aware of how they react to drug before driving or operating machinery.